Is NeuroStrip certified as a medical device?
NeuroStrip by Control Bionics is listed as a CE class I medical device. Class I is self-declared by the maker, without review by a notified body. We found no FDA authorisation.
At a glance
| Product | NeuroStrip |
|---|---|
| Maker | Control Bionics |
| Care area | Muscles, bones & rehab |
| What it does | 4-gram wearable sensor with companion app that measures muscle electrical activity (surface EMG) together with movement, for rehabilitation, research and sports |
| FDA | No FDA authorisation found |
| EU (CE) | Class I (self-declared) |
| Website | controlbionics.com |
| Status | CE class I |
| Last checked | 7 October 2026 |
Need the evidence behind this entry?
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes
Certified Health Apps Pro gives you the FDA reference number, decision date and a direct link to the official record, plus the EU certificate and notified body, for every app. See Pro · Free guide: how to check a health app in two minutes